EP3815634B1 - Thrombektomie und stent-implantationssystem - Google Patents

Thrombektomie und stent-implantationssystem

Info

Publication number
EP3815634B1
EP3815634B1 EP20204898.9A EP20204898A EP3815634B1 EP 3815634 B1 EP3815634 B1 EP 3815634B1 EP 20204898 A EP20204898 A EP 20204898A EP 3815634 B1 EP3815634 B1 EP 3815634B1
Authority
EP
European Patent Office
Prior art keywords
deployment catheter
stenting
lumen
clot
microcatheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP20204898.9A
Other languages
English (en)
French (fr)
Other versions
EP3815634C0 (de
EP3815634A1 (de
Inventor
Declan LEE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Neuravi Ltd
Original Assignee
Neuravi Ltd
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Filing date
Publication date
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Publication of EP3815634A1 publication Critical patent/EP3815634A1/de
Application granted granted Critical
Publication of EP3815634C0 publication Critical patent/EP3815634C0/de
Publication of EP3815634B1 publication Critical patent/EP3815634B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/844—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • A61B2017/22002—Angioplasty, e.g. PCTA preventing restenosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22072—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22084—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22094—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Definitions

  • the present invention generally relates devices used in removing obstructions and treating stenosis in the cerebral blood vessels during intravascular medical treatments. More specifically, the present invention relates to a multi-catheter system for bringing together the procedures of mechanical thrombectomy and stenting.
  • Atherosclerosis results from lesions which narrow and reduce the space in the lumen of vessels in the vasculature. Such lesions are usually composed of plaque, which can be fat, cholesterol, calcium, or other components of the blood. Severe occlusion or closure can impede the flow of oxygenated blood to different organs and parts of the body and result in other cardiovascular disorders such as heart attack or stroke. Narrowing of vessels, or stenosis, increases the risk that clots and other emboli can lodge at such locations, especially in the neurovascular where vessel diameters are already small.
  • Intracranial atherosclerotic disease ICAD is the narrowing of those arteries and vessels supplying blood to the brain and represents the most common proximate mechanism of ischemic stroke.
  • Treatment for vascular occlusions are well known in the art. Methods can include utilizing drugs, such as anticoagulants or anti-platelet agents, as well as medical procedures such as surgical endarterectomy, angioplasty, and stenting.
  • drugs such as anticoagulants or anti-platelet agents
  • medical procedures such as surgical endarterectomy, angioplasty, and stenting.
  • ERT endovascular revascularization treatments
  • Devices such as stentrievers, direct-aspiration systems, and other clot retrieval devices have been strongly associated with better clinical outcomes. However, these devices are primarily designed to recanalize the vessel by removing and retrieving an occluding embolus. Sufficient recanalization may not occur if there is also significant stenosis present at the occlusion site, increasing the need for implanted stents.
  • Treatment methods for addressing clots and lesions in the neurovascular in particular depend on the degree of stenosis, the shape of the target occlusion site (i.e. truncal, branching, etc.), and the patient's overall condition.
  • Mechanical procedures often involve using medical devices to retrieve an occlusive clot and then utilizing balloons and stents to open a narrowed artery.
  • a balloon is delivered to a target site and inflated to dilate the stenosis. The balloon can then be removed and exchanged through a catheter for a stent delivery device. If desirable, once the stent is in place a balloon can be inflated inside the stent to press the struts of the stent frame firmly against the inner wall of the vessel.
  • the presence of the stenosis is only identified after initial treatment options are chosen and an ERT procedure is already underway, and the devices and methods used to remove occlusions are often different from those used to treat stenosis and stent a vessel.
  • the need for shorter door-to-procedure times in is always present to limit lasting damage in ischemic stroke patients. Therefore, there remains a need for new systems and devices to continue to address and improve these treatments.
  • the present design is aimed at providing an improved system and method for treating the combined presence of clots and stenosis in the cerebral vasculature which addresses the above-stated deficiencies.
  • US 2002/095141 A1 describes a rapid exchange sheath comprising an elongate tubular member, a guidewire, and support wire having an expandable filter at a distal end.
  • the guidewire passes through a first opening at a distal end of the tubular member and a second opening a short distance proximal from the distal end.
  • the support wire is received in a lumen of the tubular member, or, in certain embodiments, extends proximally through a third opening a short distance proximal from the distal end.
  • WO 2014/008460 A2 describes new devices, systems, and methods for preventing, treating, and/or at least minimizing ischemia and/or reperfusion injury by restoring and/or modulating blood flow, particularly in the cerebral vasculature where blood vessels are narrow and tortuous. These devices, systems, and methods make it possible for a clinician to adequately and systematically restore blood flow to ischemic tissue while simultaneously modulating the blood flow to minimize reperfusion injury.
  • the directional member is made from a pliable and elongatable material with properties of blocking fluid and emboli passage.
  • the directional member is deployable within the vessel by the fluid flow in the vessel and directs the fluid in the vessel and any emboli in the fluid into the filtering member.
  • the filtering and directional members are disposed at an acute angle relative to the shaft to create a trapping pocket. Restraining wires attached to the directional member are used to collapse the directional member and draw at least a part of the directional member into an outer sheath to prevent emboli from backflowing into the vessel.
  • the invention is defined in claim 1. Further embodiments are defined in the dependent claims.
  • the surgical methods described below are not explicitly recited by the wording of the claims, but are considered as useful for understanding the invention. It is an object of the present design to provide systems, devices, and methods to meet the above-stated needs.
  • the proposed system provides for a three-catheter setup.
  • the first catheter has the largest diameter and can serve as a guide catheter while also being a deployment sheath for the other catheters.
  • the second catheter can be configured for aspiration and can include a stepped or recessed section proximal of the distal tip that can serve as a housing for a braided expandable stent.
  • FIGs. 1A-1C illustrate a system 100 capable of treating both occlusions and stenosis in a blood vessel.
  • the system 100 can have a first outer guide catheter or sheath member 102 having an internal lumen 104.
  • a second deployment catheter 106 can be disposed in the lumen 104 of the sheath member 102.
  • the sheath member 102 can act as a guide catheter for the system 100.
  • the sheath member can also serve as a deployment sleeve for the deployment catheter, protecting the rest of the system during delivery and deployment.
  • the deployment catheter 106 can have a distal end 107, an outer diameter D2, an outer surface 110, an inner lumen 108, and a flexible portion 111 disposed circumferentially in an annular pattern around the outer surface approximate the distal end.
  • the deployment catheter can also have a stepped or depressed region 120 just proximal of the distal end 107 of the catheter where the depressed region outer diameter D1 is less than the nominal deployment catheter outer diameter D2.
  • the depressed region 120 thus can represent a recess or groove-like feature of the deployment catheter.
  • An expandable stenting device 112 can be disposed concentrically to circumscribe the outer circumference of an uninflated inflation device 122 and approximate to the flexible portion 111 of the deployment catheter 106.
  • the stenting device can be disposed within the flexible portion of the deployment catheter.
  • the flexible portion 111 extends proximally from the distal end 107 of the deployment catheter 106 for a length of approximately 20 cm.
  • the braid of the stenting device 112 can be manufactured from Nitinol or a similar superelastic alloy having the shape-memory properties of a tubular structure with a predetermined outer diameter.
  • a self-expanding stenting device could be actuated by retracting the outer sheath member 102 and might not require a separate inflation device 122 for deployment, but a balloon could still be used for pre- or post-dilation of the vessel during the implantation process.
  • This tubular structure can be heat treated on a mandrel to a suitable temperature to anneal the structure, causing the tube to conform to the shape of the mandrel.
  • the elastic properties of the stent braid could be controlled such that the stent can self-expand to aid in the implantation process.
  • the properties are also important so the stent can maintain stiffness and strength over the desired lifetime of the implant.
  • the winding of the braid strands can also be sufficiently dense to provide a stable configuration capable of supporting the full inner circumference of a vessel when implanted.
  • the strands or struts of the stent can extend longitudinally and be woven in a largely helical configuration with the central axis or centerline 130 of the resulting tubular structure as a common axis.
  • a first set of strands can be wound in one direction while being axially displaced from one another.
  • a second group of strands could be wound in the opposite direction from the first while also being axially displaced relative to each other.
  • the stenting device can also be bare metal or could be coated in a number of ways.
  • the coating can be hydrophilic or have additives effective to increase the lubricity of the mesh braid of the stenting device 112 to allow for more atraumatic navigation of the vasculature.
  • the coating could be hydrogel or include soluble particles in a polymeric matrix which could soften or fully dissolve when exposed to an aqueous medium like blood.
  • the coating could have embedded pharmaceutical agents, such as anti-platelet, anti-coagulant, anti-inflammatory, or anti-microbial agents. These agents could elute from the matrix of the coating when exposed to aqueous media and help prevent the implanted stent from forming a potential nidus for future clot formation.
  • the inflation device 122 can be coupled, glued, or welded to the outer surface 110 of the deployment catheter.
  • the inflation device 122 can have one or more balloon or innertube-type members of varied construction and an expanded condition configured to expand and implant the stenting device 112. Inflation of the inflation device can be accomplished through an inflation lumen or tube 124 running the length of the deployment catheter 106.
  • the inflation tube can occasionally be an independent member, but more often can be a hollow lumen incorporated into the internal construction of the deployment catheter.
  • the expandable stenting device and inflation device can together circumscribe the depressed region 120 of the deployment catheter 106 and together the assembly could have a nominal radial dimension similar to the nominal outer diameter D2 of the deployment catheter.
  • the depressed region 120 within the flexible distal section 111 of the deployment catheter 106 can be a housing for the inflation device 122 and stenting device 112 during delivery of the system 100.
  • the longitudinal length of depressed region 120 could be such that the region could accommodate the most common neurovascular stent sizes.
  • a microcatheter 114 which can be disposed within the lumen 108 of the deployment catheter 106.
  • the microcatheter can be concentric with both the guide/sheath member 102 and deployment catheter 106 about the central longitudinal axis 130 of the system 100.
  • the sheath member, deployment catheter, and microcatheter can be independently moveable with respect to one another.
  • the deployment catheter can be used to first aspirate an occlusive clot 50, after which if necessary, the microcatheter can be used for the delivery and deployment of a mechanical thrombectomy device 118.
  • the mechanical thrombectomy device can be any of a number of commercially available products.
  • This atraumatic function is important for the often-fragile vessels of the neurovascular 40.
  • an expandable member or frame could be used as a flow restriction between the surfaces.
  • the low-pressure region could thereby be transferred to the distal end 107 of the deployment catheter 106.
  • the outer surface 110 of the deployment catheter 106 can also have a depressed region 120.
  • the depressed region can have a first radial dimension D1 less than a second radial dimension D2 of another region of the outer surface adjacent to the depressed region.
  • the deployment catheter 106 can have an expandable stenting device 112 coupled to the deployment catheter outer surface 110.
  • the stenting device can circumscribe the depressed region 120, such that it is substantially radially flush with the outer surface 110.
  • An inflation device 122 configured to expand the stenting device 112 can also be included and coupled to the outer surface of the deployment catheter.
  • the inflation device is a circumferential balloon that could be inflated by a contrast liquid media. At least a portion of the stenting device 112 can circumscribe the inflation device 122.
  • radiopaque markers or coils can also be added to various portions of the device and/or catheter to aid the user in determining when the device is appropriately positioned across the clot.
  • a coil of radiopaque material such as tungsten and/or platinum, can be attached to the distal end of the thrombectomy device so that the terminal end can be visualized readily during the treatment procedure.
  • the thrombectomy device 118 can be unsheathed as the microcatheter 114 is withdrawn proximally, allowing the thrombectomy device to expand within and to either side of the clot 50, as shown in FIG. 3B .
  • the scaffold of the capture portion of the device expands to grip portions of the clot.
  • the stenting device 112 can be a self-expanding structure configured to assume a predetermined outer diameter when deployed without the need for an inflation device 122.
  • the outer diameter for the device can be chosen such that a desired radial force is applied to the vessel and an implant diameter D3 sufficient to recanalize flow.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Claims (9)

  1. Thrombektomie- und Stentimplantationssystem (100) zum Entfernen eines Gerinnsels aus einem Blutgefäß (40) und für eine Stentimplantation in das Blutgefäß, das System (100) umfassend:
    ein Hüllenelement (102), umfassend ein Hüllenlumen (104);
    einen Einsetzkatheter (106), der innerhalb des Hüllenlumens (104) ausgerichtet ist, der Einsetzkatheter (106) umfassend ein Einsetzkatheterlumen (108) und eine Einsetzkatheteraußenoberfläche (110);
    eine Stentimplantationsvorrichtung (112), die die Einsetzkatheteraußenoberfläche (110) umgibt;
    eine Thrombektomievorrichtung (118);
    einen Mikrokatheter (114), der in dem Einsetzkatheterlumen (108) ausgerichtet ist, wobei der Mikrokatheter (114) ein Mikrokatheterlumen (116) umfasst; und
    wobei mindestens ein Abschnitt der Thrombektomievorrichtung (118) in dem Mikrokatheterlumen (116) ausgerichtet ist;
    wobei die Thrombektomievorrichtung (118) einen expandierbaren Gerinnsellöser umfasst, der zusammenfaltbar ist, um innerhalb des Mikrokatheterlumens (116) zu passen, und bei einem Verlassen des Mikrokatheterlumens (116) selbstexpandierbar ist; und wobei
    der Gerinnsellöser einen Gerinnselgreifabschnitt umfasst, der Gerinnselgreifabschnitt umfassend ein expandierbares Netzwerk von Streben, die konfiguriert sind, um das Gerinnsel zu greifen und es aus dem Blutgefäß (40) zu lösen.
  2. System (100) nach Anspruch 1, wobei der Einsetzkatheter (106) ferner umfasst:
    einen Einsetzkatheteraußendurchmesser (D2); und
    einen vertieften Bereich (120) auf der Einsetzkatheteraußenoberfläche (110) und in der Nähe eines distalen Endes des Einsetzkatheters (107), umfassend einen Außendurchmesser (D1) des vertieften Bereichs, der kleiner als der Außendurchmesser (D2) des Einsetzkatheters ist.
  3. System (100) nach Anspruch 2, wobei die Stentimplantationsvorrichtung (112) den vertieften Bereich (120) des Einsetzkatheters (108) umgibt.
  4. System (100) nach Anspruch 1, ferner umfassend:
    eine Aufblasvorrichtung (122), die mit der Einsetzkatheteraußenoberfläche (110) verbunden ist,
    wobei ein Abschnitt der Stentimplantationsvorrichtung (112) die Aufblasvorrichtung (122) umgibt und
    wobei die Aufblasvorrichtung (122) einen expandierten Zustand aufweist, der konfiguriert ist, um die Stentimplantationsvorrichtung (112) zu expandieren.
  5. System (100) nach Anspruch 1, wobei das Hüllenlumen, das Einsetzkatheterlumen (106) und das Mikrokatheterlumen (114) im Wesentlichen konzentrisch sind.
  6. System (100) nach Anspruch 1, wobei der Einsetzkatheter (106) einen flexiblen Abschnitt (111) nahe der Stentimplantationsvorrichtung umfasst.
  7. System nach Anspruch 1, wobei das Hüllenelement (102), der Einsetzkatheter (106) und der Mikrokatheter (114) im Wesentlichen konzentrisch sind und konfiguriert sind, um sich unabhängig voneinander entlang einer Achse (A1) zu bewegen.
  8. System (100) nach Anspruch 7, wobei der Einsetzkatheter (106) ferner einen vertieften Bereich (120) auf der Außenoberfläche (110) des Einsetzkatheters umfasst, wobei der vertiefte Bereich (120) eine Abmessung (D1) umfasst, die kleiner als eine Abmessung (D2) eines anderen Bereichs der Außenoberfläche des Einsetzkatheters neben dem vertieften Bereich (120) ist.
  9. System (100) nach Anspruch 8, wobei die Stentimplantationsvorrichtung (112) den vertieften Bereich (120) des Einsetzkatheters (108) umgibt.
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US12171449B2 (en) 2024-12-24
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